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Generic Version of Wellbutrin SR Approved in 100mg Dose

HAYWARD, Calif., Jan 28, 2004 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (NASDAQ:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of Wellbutrin(R) SR (Bupropion Hydrochloride) 100 mg Controlled Release Tablets and has granted tentative approval to the Company's generic version of Wellbutrin SR 150 mg Controlled Release Tablets. GlaxoSmithKline (NYSE:GSK) markets Wellbutrin SR for the treatment of depression. According to NDCHealth, U.S. sales of these dosage forms of Wellbutrin SR Tablets were approximately $1.6 billion in the 12 months ended November 30, 2003.

Conversion of the 150 mg strength tentative approval to final approval is contingent upon any generic marketing exclusivity. Final approval also is dependent upon FDA's evaluation of any new information subsequent to the tentative approval.

"We are pleased to have received these important approvals and continue to work diligently with our partners, Teva (NASDAQ:TEVA) and Andrx (NASDAQ:ADRX), toward the final approval of the 150 mg strength," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President.

IMPAX currently has 20 applications pending at the FDA, including five tentatively approved, which address over $7 billion in U.S. market sales for the 12 months ended November 30, 2003. Fifteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

Source: IMPAX Laboratories, Inc.

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